SOP for vendor audit

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SOP for vendor audit

 

 

OBJECTIVE:To define the procedure for vendor approval and qualification of vendor.

 

SCOPE:This SOP applies for procedure of vendor approval to all incoming raw materials and packaging material. This SOP also applies to qualify vendor, approved vendor list.

 

REFERENCE:Inhouse

 

RESPONSIBILITY:

QA Incharge/QA officer: To conduct vendor audit, approval of vendor & preparation of approved vendor list.

Store Incharge/Store officer: To follow the procedure as per SOP.

QC Incharge/QC officer: To analyse the sample as per SOP.

DISTRIBUTION:

Sr. No Particular Departments

QA QC PD ST MB EHS PR MT

1 Master copy no. 1

2 Control copy no. 1 2

3 Total control copies 2+1 Copy to purchase department

ABBREVATIONS:

SOP: Standard Operating Procedure

QA: Quality assurance

HOD: Head of the department

API: Active Pharmaceutical Ingredient

ISO: International Organization for Standardization

GMP: Good Manufacturing Practices

USFDA: United States Food & Drug Administration

UK-MHRA: United Kingdom Medicines and Healthcare products Regulatory Agency

CAPA: Corrective and Preventive Action

 

 

PROCEDURE:

 

1. Get a list / name of vendors to be developed from Purchase Department.

2. Vendor Development shall be performed in following cases:

2.1 New requirement of raw materials.

2.2 Supply of poor quality raw materials from existing vendor.

2.3 Exiting vendor unable to fulfill requirement in terms quantity.

2.4 Introduction of new vendors.

2.5 Commercial and other reasons.

3. Vendor approval process for Active Material

3.1 Send Questionnaire through purchase department to vendor as per applicable format for Active material as per Annexure – I.

3.2 After receiving filled questionnaire along with TSE/BSE certificates and other related attachments, Quality Assurance will evaluate the vendor for the suitability.

3.3 After Q.A. Manager or his designate for active material, if manufacturer has no GMP status or ISO certification and/or no previous history of supply  to company name then the audit shall be conducted before procurement of Active material.

3.4 If manufacturer for Active material, has GMP status or ISO certification and/or previous history of supply to company name then procurement of Active material can be allowed to purchase department.

3.5 Meanwhile Q.A. Manager or his designate will plan to audit the vendors manufacturing site.

3.6 Team of 2-3 persons (Quality system Manager &/or Executive, Production &/or Manager/Executive, Purchase executive) will visit vendor site and inspect and audit report will be prepared as per Annexure – IV.

3.7 In case of any major change in manufacturing process / equipment by existing vendor, three samples from three different batches shall be obtained along with Certificate of Analysis, Specification & Testing Method, Material Safety Data Sheet etc.

3.8 Samples will be forwarded by Purchase Department to Q.A. Manager.

3.9 Quality Control will analyze all the samples and forward to Product Development Laboratory for lab trials.

3.10 Product Development Laboratory will take trial & prepare report and forward it to Q.A.

3.11 Q.A. Manager will comment about the suitability of material.

3.12 If suitable, Q.A. will communicate to Purchase Department for order of material.

3.13 After finding suitability of material supplied by vendor, the same vendor’s name shall be included in Approved vender list as per Annexure-V or VI.

3.14 The audit calendar shall be prepared for audit and audit shall be conducted by QA Manager and/or his designate and/or authorized persons appointed by QA.

3.15 For Active material, vendor shall be audited once in three years.

4. Vendor approval process for excipients and solvents

4.1 Send Questionnaire through purchase department to vendor as per applicable format for excipients and solvent materials as per Annexure – II.

4.2 After receiving filled questionnaire, along with TSE/BSE certificates, Residual Solvent Statement and other related attachments, Quality Assurance will evaluate the vendor for the suitability.

4.3 After Q.A Manager or his designate feel satisfactory based on questionnaire, its name shall be added in vendor list and purchase department will start procedure for material procurement.

4.5 Further process will be done as per Sr. No. 3.7 to 3.13.

4.6 Vendor shall be audited once in a 5 years for excipients and solvents if any.

5. Vendor approval process for Packaging Material

5.1 Send Questionnaire through purchase department to vendor as per Annexure – III.

5.2 After receiving filled questionnaire, along with Food grade certificate, TSE/BSE certificate and other related attachments, Quality Assurance will evaluate the vendor for the suitability.

5.3 After Q.A. Manager or his designate for primary packaging material, if manufacturer has no GMP status or ISO certification and/or no previous history of supply to company name then the audit shall be conducted before procurement of packaging material.

5.4 If manufacturer for primary packaging material, has GMP status or ISO certification and/or previous history of supply to company name then procurement of Packaging material can be allowed to purchase department.

5.5 Meanwhile Q.A Manager or his designate will plan to audit the vendors manufacturing site.

6. Approved vendor list and its revision

6.1 The Approved vendor list will be prepared when introduced new product & will be reviewed once in a two year by Q.A. dept. The controlled photocopies will be forwarded to warehouse, Q.C. & purchase department for their reference.

6.2 Further purchase department will purchase material from approved vendor.

7. New Vendor Development

7.1 If the vendor is well established in market in following terms, it can be added to the approved vendor list with lenient risk analysis –

7.1.1 If the vendor is well known in local or international market for more than 10 years.

7.1.2 If the vendor is accredited with WHO or USFDA or UK-MHRA cGMP certificates and having ISO certification.

7.2 For the approval of completely new vendor for API ask for three samples from three different batches (samples for the material manufactured under batch process) and three samples of three different days (for the material manufactured under continuous process).

7.3 After receiving the samples, Q.C. will analyse above samples as per laid down specification and any special test decided based on case to case basis. Q.C. will also give these samples to Product Development department for performance trial.

7.4 Product Development department shall take lab scale batches and assess the suitability of material in terms of Quality and Yield and other critical parameters wherever applicable.

Process Development Laboratory shall forward their report to Q.A. Department.

7.5 Quality Assurance Department & technical director will review the report & will send sample evaluation report to Purchase Department with comments as per Annexure-VII. Depending on the comments, Purchase Department will take the action.

7.6 If sample evaluation report is satisfactory, Q.A. will add name of manufacturer in vendor approved list and same will be informed to purchase department for their action.

7.7 After receiving the consignment material will be sampled as per sampling procedure and analysed as per laid down specification. If the material passes, Quality Control will release this material.

7.8 After getting quality of 1st commercial batch satisfactory, stability study will be conducted of this batch manufactured with material of new vendor.

7.9 Vendor approved list will be prepared product wise for raw material as per Annexure-V. Also packaging material vendor approved list is prepared as per Annexure- VI.

7.10 Approved Vendor list will be updated once in a two year.

7.11 Name of the vendor may be deleted from the list at the time of review.

8. Receipt of material from non-approved vendor

8.1 In case material is purchased without evaluation of sample from non-approved vendor due to commercial reason, or non-availability of material with approved vendor, material will be accepted only after the analysis as per specification.

8.2 After release trial batches will be conducted in Product development department for confirmation the suitability and vendors name will be added in alternative vendor list.

8.3 If report of 3 trial batches of Product development department is satisfactory, material will be used for commercial manufacturing and the alternative vendor name will be moved in to approve vendor list.

8.4 If report of 3 trial batches is not satisfactory, material will be rejected and the name of vendor will be removed from alternative vendor list.

8.5 In case of key raw material after manufacturing 1st commercial batch and if complies, stability will be conducted.

9. Evaluation and rejection criteria of existing API Material vendor

9.1 If consignment from approved vendor gets rejected more than 3 times for non quality related matter re-audit will be done and CAPA plan will be decided with their concern person.

9.2 Effectiveness of CAPA will be review during future supply. If CAPA found ineffective then warning given to said vendor for immediate upgradation.

If consignment got reject in quality parameters, matter is immediately reported to concern vendor for CAPA plan. Reaudit will be done.

9.3 Next consignment from vendor applicable for point no. 9.2 will analysed carefully for effectiveness of CAPA, If CAPA will found ineffective then said material is rejected and vendor is disqualified and name is removed from vendor list.

9.4 Vendors applicable for point 9.1 and 9.2, will be given low priority during procurement of material.

9.5 Review of consistent supply of API is taken once in a year and the vendor/supplier whose performance is not proper are omitted from vendor list.

9.6 If Vendor/supplier which have omitted from vendor list (applicable for 9.5) want to continue supply will be qualified again.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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